Text Size

Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury

This study is currently recruiting participants.
Verified April 2013 by StemCells, Inc.
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.
ClinicalTrials.gov Identifier:
NCT01321333
First received: March 21, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.


Condition Intervention Phase
Thoracic Spinal Cord Injury
Spinal Cord Injury
Spinal Cord Injury Thoracic
Spinal Cord Trauma
 Procedure: HuCNS-SC cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by StemCells, Inc.:

Primary Outcome Measures:
  • Types and frequencies of adverse events and serious adverse events [ Time Frame: One year after transplant ] [ Designated as safety issue: Yes ]
    Analysis of types and frequencies of adverse events one year after transplant.


Estimated Enrollment: 12
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HuCNS-SC cells Procedure: HuCNS-SC cells
single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
Other Names:
  • Human central nervous system stem cells
  • allogeneic stem cells

Detailed Description:

Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)
  • T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)
  • ASIA Impairment Scale (AIS) Grade A, B, or C
  • Minimum of six weeks post injury for the initiation of screening
  • Must have evidence of preserved conus function
  • Must be at stable stage of medical recovery after injury

Exclusion Criteria:

  • History of traumatic brain injury without recovery
  • Penetrating spinal cord injury
  • Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma
  • Previous organ, tissue or bone marrow transplantation
  • Previous participation in any gene transfer or cell transplant trial
  • Current or prior malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321333

Contacts
Contact: Tina Lung-Porter, Study Nurse 0041 44 386 5970 stemcells.pz@balgrist.ch

Locations
Switzerland
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340 Recruiting
Zurich, Switzerland, 8008
Contact: Armin Curt, MD     41-44-386 3901        
Contact: Dagmar Keller-Lang, MD     41 44 386 39 05     Dagmar.Keller@balgrist.ch    
Principal Investigator: Armin Curt, MD            
Sponsors and Collaborators
StemCells, Inc.
Investigators
Principal Investigator: Armin Curt, MD University Hospital Balgrist
  More Information

Additional Information:
spinal cord injury trial  This link exits the ClinicalTrials.gov site
Information on study in German- University Hospital Balgrist  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT01321333     History of Changes
Other Study ID Numbers: CL-N02-SC
Study First Received: March 21, 2011
Last Updated: April 23, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by StemCells, Inc.:
thoracic spinal cord injury
spinal cord injury thoracic
sub-acute spinal cord injury
human neural stem cells
 stem cells
stem cells transplant
stem cells transplant spinal cord injury

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Thoracic Injuries
Wounds and Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
 Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 19, 2013